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Metabolic Solutions, Inc.

USA · Nashua

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Singapore — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 2Class II 2Class III 0

plus 5 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States5 registration records, 5 510(k), 0 PMA, 4 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: GT METABOLIC SOLUTIONS, INC.

FDA 510(k) clearances by year

11999 · K990931

22024 · K242086

12025 · K243359

12026 · K253102

FDA listed device types

Magnetic Compression Anastomosis System 1Endoscopic Magnetic Retriever, Exempt 1Instrument, Manual, Surgical, General Use 1Retractor 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253102	GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)	2026-06-04
US	K243359	MagDI System (MAG-02, DS-01)	2025-02-28
US	K242086	MagDI System (MAG-01, DS-01)	2024-10-24
BR	80065329003	GT Metabolic Magnetic Retrieval Device (MRD) - Dispositivo de Recupera	Class II

Metabolic Solutions, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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